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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tampon, menstrual, unscented
510(k) Number K883867
Device Name CERVICAL BIOPSY INSTRUMENT
Applicant
MEND TECHNOLOGIES, INC.
5757 ALPHA RD.
SUITE 304
DALLAS,  TX  75240
Applicant Contact T. H PARKE
Correspondent
MEND TECHNOLOGIES, INC.
5757 ALPHA RD.
SUITE 304
DALLAS,  TX  75240
Correspondent Contact T. H PARKE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/13/1988
Decision Date 11/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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